Safety tests

A cosmetic product that comes into contact with our body and, in particular, with its most delicate and intimate areas, must be safe and effective first of all.

Ekuberg Pharma renews its ethical commitment towards the customers every day, offering a product that completely reflects their expectations regarding quality and safety.

The safety of all DermoXEN products is guaranteed from the choice of raw materials, which must pass strict quality controls, to the introduction in the market of the end product, that first undergoes in vitro laboratory tests and in vivo clinical trials, under the careful supervision of dermatologists and gynaecologists.

Every batch of DermoXEN products is tested to check whether the presence of heavy metals, such  as Nickel, Chrome, CobaltMercury and Palladium, that can result from the manufacturing process, is always in a minimum quantity considered NON ALLERGENIC by the international scientific literature.

The cosmetic product is brought into contact with the in vitro reconstructed skin model for 18 hours. The irritation potential is determined by the assessment of cell viability (vs positive and negative control), and by measuring the release and production of inflammatory mediators, such as Lactate dehydrogenase, a cytoplasmic enzyme, whose release indicates a loss of cell membrane integrity, and Interleukin 1α, a cytokine that plays a key role in the inflammatory process.

An ingredient or a product are considered NON IRRITATING in the absence of cytotoxicity and if there is no significant increase in pro-inflammatory cytokine release.

After these tests, all DermoXEN products have been classified as NON IRRITATING to the skin.

Thanks to this in vitro test, the irritation potential of feminine hygiene products on a reconstructed human vaginal epithelium is assessed. The product is brought into contact with the epithelium for 18 hours. Exposure time necessary to decrease the tissue viability to 50% (ET50) is calculated. The production of lactate dehydrogenase, a cytoplasmic enzyme whose release indicates a loss of cell membrane integrity, is also evaluated.

After these tests, all DermoXEN products have been classified as NON IRRITATING to the skin.

The whole line of DermoXEN products has been tested in vivo on 20 healthy volunteers in order to assess skin compatibility. Dermatological test has been carried out through an occlusive patch test, applied to the skin of the back of each volunteer, for 48 hours.

Skin compatibility of the product has been assessed by a dermatologist 15 minutes and 24 hours after the removal of the patch. The following parameters have been considered: erythema and oedema.

After this test, all DermoXEN products have been classified as NON IRRITATING to the skin.

Nickel, Chrome, Cobalt, Mercury and Palladium are heavy metals that can be highly allergenic for human beings. We find them in nature, in many metal objects, but also in some detergents, in cosmetics, in dyes and, in small amount, also in food.

In order to guarantee to the customer that the products coming into contact with the skin are safe, Ekuberg Pharma carries out specific tests on every production batch which allow to determine that heavy metal concentrations are lower than  0,00001%.

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